A Prospective Trial of a Bio-absorbable Mesh in Challenging Laparoscopic Ventral or Incisional Hernia Repair

Subjects at high risk are defined as having 1 or more of the following co-morbid conditions: body mass index (BMI) between 30-40 kg/m2, inclusive, active smokers, chronic obstructive pulmonary disease (COPD), diabetes, immunosuppression, coronary artery disease, chronic corticosteroid use, low pre-operative serum albumin, advanced age, or renal insufficiency.

Inclusion criteria

• Subject must be 18 years of age or older
• Subject must be willing to give written informed consent
• Subject must be diagnosed with ventral or abdominal incisional hernia
• Subject must be willing to undergo laparoscopic hernia repair using intraabdominal placement (with or without Component Separation Technique (CST))
• Surgeon must be able to fully close the hernia defect. Defect closure is defined as complete reapproximation of fascial edges, leaving no gap. Since the safety and effectiveness of Phasix™ ST Mesh in bridging repairs has not been evaluated or established, the defect should be closed prior to mesh use.
• Subject is expected to meet the criteria for a Class I wound
• Subjects must have 1 or more of the following pre-study conditions:

• Body Mass Index (BMI) between 30-40 kg/m2, inclusive
• Active smoker (including if attempts to quit smoking within two weeks of surgery have failed and the patient is still an active smoker at the time of surgery)
• COPD presence on patient self-report
• Diabetes mellitus (if yes, diagnosis to be confirmed via medical records or laboratory results according to 2014 Joslin Clinical Guideline for Adults with Diabetes)(Appendix 5)
• Immunosuppression
• Coronary Artery Disease
• Chronic corticosteroid use: greater than 6 months systemic use
• Serum albumin less than 3.4 g/dL
• Advanced age: 75 years or older
• Renal insufficiency, defined as serum creatinine concentration ≥2.5 mg/dL

Exclusion criteria

• Subject has had 4 or more previous hernia repairs (of the index hernia)
• Subject's hernia is > 350 cm2
• Complete removal of existing mesh from a prior hernia repair (in the same affected area) is not possible
• Subject has intact permanent mesh adjacent to the current hernia to be repaired
• Preperitoneal placement of mesh
• The subject is known to have a collagen disorder
• The subject has peritonitis
• The subject is on or suspected to be placed on chemotherapy medications during any part of the study
• The subject's Body Mass Index (BMI) is > 40 kg/m2
• The subject has cirrhosis of the liver and/or ascites
• Subject is American Society of Anesthesiology Class 4 or 5
• Subject has a life expectancy of less than 2 years at the time of enrollment
• Subject has any condition that, in the opinion of the Investigator, would preclude the use of the study device, or preclude the subject from completing the follow-up requirements
• Subject has a surgical wound classified as Class II (Clean-Contaminated), Class III (Contaminated) or Class IV (Dirty-Contaminated)
• Subject has an active or latent systemic infection
• Patient has a contraindication to placement of mesh
• Subject requires surgical bridge repair as the sole repair
• Subject is pregnant or has plans to become pregnant during the study period
• Subject has enrolled in another interventional clinical study within the last 30 days
• Subject is part of the site personnel directly involved with this study
• Subject has a known allergy to the test device or component materials (patients with known allergies to tetracycline hydrochloride or kanamycin sulfate should be avoided).